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Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed PMBL
Sponsor: National Research Center for Hematology, Russia
Summary
This compares the effects of nivolumab at a fixed dose of 40 mg with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.
Official title: Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-04-01
Completion Date
2029-04-01
Last Updated
2024-01-03
Healthy Volunteers
No
Conditions
Interventions
Cyclophosphamide
Ciclofosfamida
Doxorubicin Hydrochloride
Adriamycin
Etoposide Phosphate
Etopophos
Prednisolone
Prednisolonum
Rituximab
Chimeric Anti-CD20 Antibody
Vincristine Sulfate
Oncovin
Filgrastim
G-CSF
Pegfilgrastim
PEG-filgrastim
Nivolumab 40 mg in 4 ml Injection
Opdivo
Locations (1)
National Research Center for Hematology
Moscow, Russia